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Sensoronics SC-SPNE-8REC

by Sensoronics Incorporated

Sensoronics SC-SPNE-8REC is a Class II device made by Sensoronics Incorporated, cleared under FDA 510(k) K120010 on 19 Jan 2012 and listed in FDA GUDID since 12 Oct 2016 (UDI-DI 00851457007247), 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) K120010

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 Number00851457007247 UDI-DI Date12 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120010 Date19 Jan 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120010 decided 19 Jan 2012 Active
  • FDA GUDID UDI-DI 00851457007247 listed 12 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120010
  2. Listed FDA GUDID 00851457007247

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sensoronics
Generic name
Electrical-only medical device connection cable, reusable
Model / reference
SC-SPNE-8REC
Primary DI / UDI-DI
00851457007247
510(k) Number
FDA product code
DSA
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class II
Regulation number
870.2900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K120010)

and 8 more cleared under K120010

Similar devices in this category

Other devices filed under Electrical-only medical device connection cable, reusable.

Other devices from Sensoronics Incorporated

See all devices from Sensoronics Incorporated →

Properties

  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)