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Pilling IPN004243

by Teleflex Incorporated

Pilling IPN004243 (200200) is a dissection sponge (FDA Class I; FDA product code GDY, Gauze/Sponge, Internal, X-Ray Detectable) made by Teleflex Incorporated, cleared under FDA 510(k) K913302 on 23 Jul 1992 and listed in FDA GUDID since 15 Sep 2018 (UDI-DI 04026704417605), 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) K913302

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 Number04026704417605 UDI-DI Date15 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK913302 Date23 Jul 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K913302 decided 23 Jul 1992 Active
  • FDA GUDID UDI-DI 04026704417605 listed 15 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K913302
  2. Listed FDA GUDID 04026704417605

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pilling
Generic name
Dissection sponge
Model / Ref / Catalog
IPN004243, 200200
Primary DI / UDI-DI
04026704417605
510(k) Number
FDA product code
GDY
GMDN term
Dissection sponge
Device class
Class I
Regulation number
878.4450
GUDID distribution status
In Commercial Distribution
Size
Length — 4 Inch
Width — 2.25 Inch

Related devices

Category: Dissection sponge

Cleared under the same submission (K913302)

and 8 more cleared under K913302

Similar devices

Other devices filed under FDA product code GDY (GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE).

Other devices from Teleflex Incorporated

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    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)