510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800162Substantially Equivalent

Once Tm

G.D. Searle and Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800162 is the FDA 510(k) clearance record for ONCE TM, a class II device, cleared for G.D. Searle and Co. on under FDA product code HDW (Diaphragm, Contraceptive (And Accessories)). FDA records list 56 510(k) clearances for G.D. Searle and Co., from to . As of , FDA records show no recalls naming K800162.

Clearance record

Decision date
Received
(17 days to decision)
Product code
HDW Diaphragm, Contraceptive (And Accessories)
Regulation
21 CFR 884.5350
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
G.D. Searle and Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HDW

Trailing 12 months

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

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