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SunMed 8-1053-TL

by SunMed

SunMed 8-1053-TL is a Class II device made by SunMed, cleared under FDA 510(k) K121743 on 28 Mar 2013 and listed in FDA GUDID since 1 Aug 2023 (UDI-DI 10889483171486), 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) K121743

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 Number10889483171486 UDI-DI Date1 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121743 Date28 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121743 decided 28 Mar 2013 Active
  • FDA GUDID UDI-DI 10889483171486 listed 1 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121743
  2. Listed FDA GUDID 10889483171486

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SunMed
Generic name
Block-monitoring peripheral nerve electrical stimulation system
Model / Ref / Catalog
8-1053-TL
Primary DI / UDI-DI
10889483171486
510(k) Number
FDA product code
BXN
GMDN term
Block-monitoring peripheral nerve electrical stimulation system
Device class
Class II
Regulation number
868.2775
GUDID distribution status
In Commercial Distribution

Related devices

Category: Block-monitoring peripheral nerve electrical stimulation system

Cleared under the same submission (K121743)

and 8 more cleared under K121743

Similar devices

Other devices filed under FDA product code BXN (STIMULATOR, NERVE, BATTERY-POWERED).

Other devices from SunMed

See all devices from SunMed →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)