FDA PRODUCT CODE · CLASS I
NBH — Accessories, Arthroscopic
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
510(K) Exempt
SPEQ READINGNo premarket notification is required for a device in this code, within the limitations of exemption. Exempt from premarket review is NOT exempt from regulation: registration, listing, labelling, adverse-event reporting and — unless the code is also GMP exempt — 21 CFR Part 820 all still apply.
Class I (low to moderate risk): general controls
SPEQ READINGGeneral controls carry the whole regulatory burden here — registration, listing, labelling, adverse-event reporting and prohibitions against adulteration and misbranding.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Other product codes under 21 CFR 888.1100
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 888.1100 — Arthroscope
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
(b) Classification.
(1) Class II (performance standards).
(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, 2001]
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 22, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 888.1100 on eCFR →
Recent recalls
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.
Endofemoral Aimer tip may separate due to failure of the soldered joint
Endofemoral Aimer tip may separate due to failure of the soldered joint
Endofemoral Aimer tip may separate due to failure of the soldered joint
Endofemoral Aimer tip may separate due to failure of the soldered joint
Endofemoral Aimer tip may separate due to failure of the soldered joint
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →