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Soft Flex Probe Cover 20-PC324

by Advance Medical Designs, Inc.

Soft Flex Probe Cover 20-PC324 is a Class II device made by Advance Medical Designs, Inc., cleared under FDA 510(k) K011265 on 30 Oct 2001 and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 00848340019470), 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) K011265

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 Number00848340019470 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011265 Date30 Oct 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011265 decided 30 Oct 2001 Active
  • FDA GUDID UDI-DI 00848340019470 listed 13 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K011265
  2. Listed FDA GUDID 00848340019470

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Soft Flex Probe Cover
Generic name
Medical equipment/instrument drape, single-use
Model / reference
20-PC324
Primary DI / UDI-DI
00848340019470
510(k) Number
FDA product code
ITX
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

From the manufacturer

Manufacturer's product page: Probe Covers

Related devices

Category: Medical equipment/instrument drape, single-use

Cleared under the same submission (K011265)

and 8 more cleared under K011265

Similar devices in this category

Other devices filed under Medical equipment/instrument drape, single-use.

Other devices from Advance Medical Designs, Inc.

See all devices from Advance Medical Designs, Inc. →

Properties

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