510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K902516Substantially Equivalent

New Length Sugita Appliers

Sims Surgical, Inc., Keene NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902516 is the FDA 510(k) clearance record for NEW LENGTH SUGITA APPLIERS, a class II device, cleared for Sims Surgical, Inc. on under FDA product code HIC (Speculum, Vaginal, Nonmetal, Fiberoptic). FDA records list 3 510(k) clearances for Sims Surgical, Inc., from to . As of , FDA records show no recalls naming K902516.

Clearance record

Decision date
Received
(26 days to decision)
Product code
HIC Speculum, Vaginal, Nonmetal, Fiberoptic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sims Surgical, Inc. 15 Kit St., Keene NH
Third party review
No

Clearances, product code HIC

Trailing 12 months

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

FDA records show no clearances under product code HIC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HIC, 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