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FDA PRODUCT CODE · CLASS III

KNH — Laparoscopic Contraceptive Tubal Occlusion Device

Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))

DEVICE CLASS
Class III
REGULATION
21 CFR 884.5380
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P920046Femcare , Ltd. · pma2024-12-03

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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