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Teleflex IPN928802

by Teleflex Incorporated

Teleflex IPN928802 (SGS23R) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K210278 on 28 Apr 2021 and listed in FDA GUDID since 13 May 2025 (UDI-DI 14026704921727), 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) K210278

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 Number14026704921727 UDI-DI Date13 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210278 Date28 Apr 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210278 decided 28 Apr 2021 Active
  • FDA GUDID UDI-DI 14026704921727 listed 13 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210278
  2. Listed FDA GUDID 14026704921727

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Teleflex
Generic name
Endoscopic motorized cutting stapler, single-use
Model / Ref / Catalog
IPN928802, SGS23R
Primary DI / UDI-DI
14026704921727
510(k) Number
FDA product code
GDW
GMDN term
Endoscopic motorized cutting stapler, single-use
Device class
Class II
Regulation number
878.4750
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Endoscopic motorized cutting stapler, single-use

Cleared under the same submission (K210278)

and 3 more cleared under K210278

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    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)