← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

EOB — Nasopharyngoscope (Flexible Or Rigid)

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

DEVICE CLASS
Class II
REGULATION
21 CFR 874.4760
MEDICAL SPECIALTY
Ear, Nose, Throat
REVIEW PANEL
EN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K261544Stryker Instruments · 510k2026-06-17
K254133Optim, LLC · 510k2026-05-14
K253184Zhuhai Wesee Meditech Co., Ltd. · 510k2026-03-25
K252050Olympus Medical Systems Corporation · 510k2026-03-20
K241731Resnent, LLC · 510k2025-08-11
K243639Grumpy Innovation, Inc. · 510k2025-06-05
K243380Olympus Medical Systems Corporation · 510k2025-03-03
K234096Medicaltek Co., Ltd. · 510k2024-09-19

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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