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Tonsil Sponges 50-01

by American Surgical Company, LLC

Tonsil Sponges 50-01 is a dissection sponge (FDA unclassified; FDA product code EFQ, Gauze/Sponge, Internal) made by American Surgical Company, LLC, cleared under FDA 510(k) K872806 on 4 Aug 1987 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 20749915000753), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K872806

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20749915000753 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK872806 Date4 Aug 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K872806 decided 4 Aug 1987 Active
  • FDA GUDID UDI-DI 20749915000753 listed 30 Jun 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1763-2016 FDA Class II initiated 31 Mar 2016

    Product packaging defective compromising sterility

Timeline

3 dated events

  1. Cleared FDA 510(k) K872806
  2. Recall initiated FDA recalls Z-1763-2016
  3. Listed FDA GUDID 20749915000753

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tonsil Sponges
Generic name
Dissection sponge
Model / reference
50-01
Primary DI / UDI-DI
20749915000753
510(k) Number
FDA product code
EFQ
GMDN term
Dissection sponge
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dissection sponge

Cleared under the same submission (K872806)

Similar devices

Other devices filed under FDA product code EFQ (Gauze/Sponge, Internal).

Other devices from American Surgical Company, LLC

  • ArmourSorb 88-04

    Class II

  • Uniqcot 67-06

    Class II

  • Uniqcot 67-86

    Class II

  • Tapered Delicot 63-09T

    Class II

See all devices from American Surgical Company, LLC →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)