510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GENClass I

Forceps, General & Plastic Surgery

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GEN is the FDA product code for Forceps, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 104 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
GEN
Device name
Forceps, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
104
Ingested recalls
10

Clearances, product code GEN

By decision year
104 clearances under product code GEN with a decision year between 1976 and 2003, 1982 the highest year at 25.
Show the numbers
510(k) clearances under FDA product code GEN by decision year
YearClearances
19762
19779
19785
19795
19804
19815
198225
19832
19842
198520
19863
19876
19884
19893
19904
19912
19931
19951
20031

Applicants with the most clearances

Product code GEN
Applicants holding the most 510(k) clearances under product code GEN
ApplicantClearances
Conphar, Inc.14
The Huxley Instrument Corp.8
Artiberia6
Mill-Rose Laboratory6
Edward Weck, Inc.5
Solos Endoscopy, Inc.4
Orthopedic Equipment Co., Inc.3
Sea-Pac Trading Corp.3
Acme United Corp.2
Arthropedics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 432 companies shown, in name order