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Debakey Beck Clamp 2100-788

by Sontec Instruments, Inc.

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 9 Nov 2026

Documents

510(k) K123077

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00192896124028 UDI-DI Date27 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123077 Date14 May 2013DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Debakey Beck Clamp
Generic name
Surgical soft-tissue manipulation forceps, scissors-like, reusable
Model / Ref / Catalog
2100-788
Primary DI / UDI-DI
00192896124028
510(k) Number
FDA product code
DXC
GMDN term
Surgical soft-tissue manipulation forceps, scissors-like, reusable
Device class
Class II
Regulation number
870.4450
GUDID distribution status
In Commercial Distribution
Sterilisation method
Dry Heat Sterilization
Size
Length — 8.0 Inch

Related devices

Cleared under the same submission (K123077)

Show all (12)

Other devices from Sontec Instruments, Inc.

See all devices from Sontec Instruments, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No