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

Speculum, Vaginal, Nonmetal

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

HIB is the FDA product code for Speculum, Vaginal, Nonmetal, a class II device type, regulated under 21 CFR 884.4530. As of , FDA records hold 72 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
HIB
Device name
Speculum, Vaginal, Nonmetal
Regulation
21 CFR 884.4530
Device class
Class II
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
72
Ingested recalls
6

Clearances, product code HIB

By decision year
72 clearances under product code HIB with a decision year between 1982 and 2026, 2002 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code HIB by decision year
YearClearances
19822
19831
19843
19862
19884
19892
19902
19921
19946
19952
19961
19974
19982
19993
20002
20014
20028
20032
20043
20053
20064
20071
20082
20091
20101
20111
20121
20131
20142
20261

Applicants with the most clearances

Product code HIB
Applicants holding the most 510(k) clearances under product code HIB
ApplicantClearances
C.I.S.A. Import Export C/O Larson and Taylor3
Sol Weiss MD, Inc.3
Welch Allyn Inc3
CooperSurgical, Inc.2
Exitec, Inc.2
Femspec LLC2
Martin Medical2
Zinnanti Surgical Instruments, Inc.2
A & A Medical, Inc.1
Adept-Med Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 113 companies shown, in name order