PAINBLOCKER WA5000— 510(k) K854334

Name: FDA 510(k) clearance K854334
Creator: U.S. Food and Drug Administration
Published: 1986-04-30

Substantially Equivalent

Wallach Surgical Devices, Inc.

FDA 510(k) clearance K854334 for PAINBLOCKER WA5000, Substantially Equivalent on 1986-04-30. Applicant: Wallach Surgical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Wallach Surgical Devices, Inc.
Product code: Code GXH
Device class: Class 2
Regulation: 21 CFR 882.4250
Advisory panel: Neurology
Date received: 1985-10-28
Decision date: 1986-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXH

view all

K250371 — cryoICE cryoXT cryoablation probe (cryoXT)2025-04-10
K243677 — iovera° System2024-12-26
K243157 — AtriCure cryoICE BOX (ACM)2024-10-29
K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more2023-10-26
K220656 — iovera System2022-05-20

More clearances from Wallach Surgical Devices, Inc.

view all

K021224 — ENDOCERVICAL BLOCK NEEDLE2002-07-12
K020711 — WALLACH LOOP ELECTRODE2002-06-03
K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR2000-04-11
K992736 — WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM1999-09-29
K991669 — PMS 750 FINGERSWITCH1999-08-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.