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Saberscope™ Articulating Laparoscope SAS-A-536L

by Xenocor, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854490007045 UDI-DI Date20 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Saberscope™ Articulating Laparoscope
Generic Name
Flexible-tip video laparoscope/thoracoscope
Model / Ref / Catalog
SAS-A-536L
Primary DI / UDI-DI
00854490007045
510(k) Number
FDA Product Code
HET, GCJ, GCQ
GMDN Term
Flexible-tip video laparoscope/thoracoscope
Device Class
Class II
Regulation Number
884.1720, 876.1500
GUDID distribution status
In Commercial Distribution
Size
Length — 36 Centimeter
Outer Diameter — 5.4 Millimeter

Related devices

Cleared under the same submission (K260177)

Other devices from Xenocor, Inc.

See all devices from Xenocor, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No