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Pegasus 1000

by A.M. Surgical, Inc.

Pegasus 1000 is a rigid optical arthroscope (FDA Class II; FDA product code HRX, Arthroscope) made by A.M. Surgical, Inc., cleared under FDA 510(k) K191345 on 17 Jul 2019 and listed in FDA GUDID since 31 Jul 2019 (UDI-DI 00857915007408), active as of 22 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 22 Oct 2026

Documents

510(k) K191345

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857915007408 UDI-DI Date31 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191345 Date17 Jul 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191345 decided 17 Jul 2019 Active
  • FDA GUDID UDI-DI 00857915007408 listed 31 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191345
  2. Listed FDA GUDID 00857915007408

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pegasus
Generic name
Rigid optical arthroscope, single-use
Model / reference
1000
Primary DI / UDI-DI
00857915007408
510(k) Number
FDA product code
HRX
GMDN term
Rigid optical arthroscope, single-use
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Rigid optical arthroscope, single-use

Cleared under the same submission (K191345)

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

Other devices from A.M. Surgical, Inc.

See all devices from A.M. Surgical, Inc. →

Properties

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