510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891349Substantially Equivalent

Campion Cervical Hook

Simpson/Basye, Inc., Wilmington DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891349 is the FDA 510(k) clearance record for CAMPION CERVICAL HOOK, a class II device, cleared for Simpson/Basye, Inc. on under FDA product code HDC (Tenaculum, Uterine). FDA records list 12 510(k) clearances for Simpson/Basye, Inc., from to . As of , FDA records show no recalls naming K891349.

Clearance record

Decision date
Received
(19 days to decision)
Product code
HDC Tenaculum, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Simpson/Basye, Inc. 430 Ayre St., Wilmington DE
Third party review
No

Clearances, product code HDC

Trailing 12 months

FDA records hold no clearances under product code HDC in the trailing twelve months.

FDA records show no clearances under product code HDC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HDC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260