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Mayfield® GS560

by Integra Lifesciences Corp.

Mayfield® GS560 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K932860 on 28 Sep 1993 and listed in FDA GUDID since 25 Jul 2016 (UDI-DI 10381780256892), 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) K932860

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 Number10381780256892 UDI-DI Date25 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK932860 Date28 Sep 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K932860 decided 28 Sep 1993 Active
  • FDA GUDID UDI-DI 10381780256892 listed 25 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K932860
  2. Listed FDA GUDID 10381780256892

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mayfield®
Generic name
Skull clamp
Model / reference
GS560
Primary DI / UDI-DI
10381780256892
510(k) Number
FDA product code
HBL
GMDN term
Skull clamp
Device class
Class II
Regulation number
882.4460
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Skull clamp

Cleared under the same submission (K932860)

Similar devices in this category

Other devices filed under Skull clamp.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)