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FDA 510(k)

PAINBLOCKER WA5000

K-Number: K854334 · 1986-04-30

ApplicantWallach Surgical Devices, Inc.
Decision Date1986-04-30
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PAINBLOCKER WA5000 is the device name listed in this FDA 510(k) record. The listed applicant is Wallach Surgical Devices, Inc.. It received FDA 510(k) clearance on 1986-04-30 under 510(k) number K854334. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAINBLOCKER WA5000?

PAINBLOCKER WA5000 is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K854334.

When did PAINBLOCKER WA5000 receive FDA 510(k) clearance?

PAINBLOCKER WA5000 received FDA 510(k) clearance on 1986-04-30, under 510(k) number K854334.

Who is the listed applicant for PAINBLOCKER WA5000?

The FDA 510(k) record lists Wallach Surgical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAINBLOCKER WA5000?

The FDA product code for PAINBLOCKER WA5000 is GXH.

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Other records listing Wallach Surgical Devices, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021224ENDOCERVICAL BLOCK NEEDLEK020711WALLACH LOOP ELECTRODEK000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORK992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUMK991669PMS 750 FINGERSWITCHK983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)

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Related Devices (Code: GXH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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