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

Forceps, Biopsy, Gynecological

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HFB is the FDA product code for Forceps, Biopsy, Gynecological, a class I device type, regulated under 21 CFR 884.4530. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HFB
Device name
Forceps, Biopsy, Gynecological
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
22
Ingested recalls
1

Clearances, product code HFB

By decision year
22 clearances under product code HFB with a decision year between 1981 and 2002, 1994 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code HFB by decision year
YearClearances
19812
19821
19842
19852
19894
19902
19947
19951
20021

Applicants with the most clearances

Product code HFB
Applicants holding the most 510(k) clearances under product code HFB
ApplicantClearances
J. Sklar Mfg. Co., Inc.3
Thomasville Medical Assoc.3
Zinnanti Surgical Instruments, Inc.3
Advanced Biomedical Instruments1
Chirurgische Instrumente1
Gyneco, Inc.1
Gynescope Corp.1
Kinetic Medical Products1
Mahe-Medizintechnik1
Owens Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 157 companies shown, in name order