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ArmourSorb 88-08

by American Surgical Company, LLC

ArmourSorb 88-08 is a neurosurgical sponge (FDA Class II; FDA product code HBA, Neurosurgical Paddie) made by American Surgical Company, LLC, cleared under FDA 510(k) K112598 on 20 Jun 2013 and listed in FDA GUDID since 16 Jun 2016 (UDI-DI 20749915002382), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K112598

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 Number20749915002382 UDI-DI Date16 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK112598 Date20 Jun 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112598 decided 20 Jun 2013 Active
  • FDA GUDID UDI-DI 20749915002382 listed 16 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112598
  2. Listed FDA GUDID 20749915002382

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ArmourSorb
Generic name
Neurosurgical sponge
Model / reference
88-08
Primary DI / UDI-DI
20749915002382
510(k) Number
FDA product code
HBA
GMDN term
Neurosurgical sponge
Device class
Class II
Regulation number
882.4700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neurosurgical sponge

Cleared under the same submission (K112598)

and 7 more cleared under K112598

Similar devices

Other devices filed under FDA product code HBA (Neurosurgical Paddie).

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)