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Laparoscope 162 102 760

by SOPRO-COMEG GmbH

Laparoscope 162 102 760 is a Class II device made by SOPRO-COMEG GmbH, cleared under FDA 510(k) K945266 on 23 Feb 1995 and listed in FDA GUDID since 20 Mar 2018 (UDI-DI 04059082032207), 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) K945266

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 Number04059082032207 UDI-DI Date20 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK945266 Date23 Feb 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K945266 decided 23 Feb 1995 Active
  • FDA GUDID UDI-DI 04059082032207 listed 20 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K945266
  2. Listed FDA GUDID 04059082032207

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Laparoscope
Generic name
Rigid optical laparoscope
Model / reference
162 102 760
Primary DI / UDI-DI
04059082032207
510(k) Number
FDA product code
GCJ
GMDN term
Rigid optical laparoscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under Rigid optical laparoscope.

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Properties

  • Sterilise before use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)