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Anospec C060100

by Obp Corporation

Anospec C060100 is a Class II device made by Obp Corporation, cleared under FDA 510(k) K121604 on 27 Jul 2012 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI M648C0601000), 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) K121604

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 NumberM648C0601000 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121604 Date27 Jul 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121604 decided 27 Jul 2012 Active
  • FDA GUDID UDI-DI M648C0601000 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121604
  2. Listed FDA GUDID M648C0601000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Anospec
Generic name
Optical anoscope, single-use
Model / Ref / Catalog
C060100
Primary DI / UDI-DI
M648C0601000
510(k) Number
FDA product code
FER
GMDN term
Optical anoscope, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Optical anoscope, single-use

Cleared under the same submission (K121604)

Similar devices

Other devices filed under FDA product code FER (Anoscope And Accessories).

Other devices from Obp Corporation

See all devices from Obp Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)