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OTSC System Set 12/6 a

by Ovesco Endoscopy USA

OTSC System Set 12/6 a (100.11) is a Class II device made by Ovesco Endoscopy USA, cleared under FDA 510(k) K101428 on 1 Dec 2010 and listed in FDA GUDID since 10 Sep 2024 (UDI-DI 04260206311614), 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) K101428

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 Number04260206311614 UDI-DI Date10 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101428 Date1 Dec 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101428 decided 1 Dec 2010 Active
  • FDA GUDID UDI-DI 04260206311614 listed 10 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101428
  2. Listed FDA GUDID 04260206311614

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OTSC System Set
Generic name
Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Model / Ref / Catalog
12/6 a, 100.11
Primary DI / UDI-DI
04260206311614
510(k) Number
FDA product code
PKL
GMDN term
Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Device class
Class II
Regulation number
876.4400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

Cleared under the same submission (K101428)

and 8 more cleared under K101428

Similar devices in this category

Other devices filed under Gastrointestinal endoscopic clip, long-term, non-bioabsorbable.

Other devices from Ovesco Endoscopy USA

See all devices from Ovesco Endoscopy USA →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)