510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861443Substantially Equivalent

S1 Vaginal Packing

Surgical Specialties Corp, Readding PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861443 is the FDA 510(k) clearance record for S1 VAGINAL PACKING, cleared for Surgical Specialties, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 33 510(k) clearances for Surgical Specialties, Inc., from to . As of , FDA records show no recalls naming K861443.

Clearance record

Decision date
Received
(19 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Surgical Specialties, Inc. P.O. Box 310, Readding PA
Third party review
No

Clearances, product code EFQ

Trailing 12 months

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

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