510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853640Substantially Equivalent

Wellington Hospital Pattern Self Retaining Vaginal

Downs Surgical, Ltd., Sheffield S9 4wj, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853640 is the FDA 510(k) clearance record for WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL, a class I device, cleared for Downs Surgical , Ltd. on under FDA product code HDF (Speculum, Vaginal, Metal). FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K853640.

Clearance record

Decision date
Received
(70 days to decision)
Product code
HDF Speculum, Vaginal, Metal
Regulation
21 CFR 884.4520
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Downs Surgical , Ltd. Pkwy. Close,Pkwy., Sheffield S9 4wj, GB
Third party review
No

Clearances, product code HDF

Trailing 12 months

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

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