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Delicot 63-01

by American Surgical Company, LLC

Delicot 63-01 is a neurosurgical sponge (FDA Class II; FDA product code HBA, Neurosurgical Paddie) made by American Surgical Company, LLC, cleared under FDA 510(k) K902921 on 18 Sep 1990 and listed in FDA GUDID since 13 Jun 2016 (UDI-DI 20749915001101), active as of 23 Oct 2026. 12 FDA recalls are 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

12 closed

Documents

510(k) K902921

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 Number20749915001101 UDI-DI Date13 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK902921 Date18 Sep 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K902921 decided 18 Sep 1990 Active
  • FDA GUDID UDI-DI 20749915001101 listed 13 Jun 2016 Listed

Recalls

12 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1798-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1795-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1772-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1770-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1794-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1796-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1771-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1768-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1797-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1767-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1774-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1765-2016 FDA Class II initiated 31 Mar 2016

    Product packaging defective compromising sterility

Timeline

14 dated events

  1. Recall initiated FDA recalls Z-1770-2016
  2. Recall initiated FDA recalls Z-1794-2016
  3. Recall initiated FDA recalls Z-1796-2016
  4. Recall initiated FDA recalls Z-1771-2016
  5. Recall initiated FDA recalls Z-1768-2016
  6. Recall initiated FDA recalls Z-1797-2016
  7. Recall initiated FDA recalls Z-1767-2016
  8. Recall initiated FDA recalls Z-1774-2016
  9. Recall initiated FDA recalls Z-1765-2016
  10. Listed FDA GUDID 20749915001101

4 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Delicot
Generic name
Neurosurgical sponge
Model / reference
63-01
Primary DI / UDI-DI
20749915001101
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 (K902921)

and 8 more cleared under K902921

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)