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FDA 510(k)

PNEUMO-SEAL(TM)

K-Number: K914470 · 1991-11-29

ApplicantEdward Weck, Inc.
Decision Date1991-11-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PNEUMO-SEAL(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1991-11-29 under 510(k) number K914470. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMO-SEAL(TM)?

PNEUMO-SEAL(TM) is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Edward Weck, Inc.. The 510(k) number is K914470.

When did PNEUMO-SEAL(TM) receive FDA 510(k) clearance?

PNEUMO-SEAL(TM) received FDA 510(k) clearance on 1991-11-29, under 510(k) number K914470.

Who is the listed applicant for PNEUMO-SEAL(TM)?

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

What is the FDA product code for PNEUMO-SEAL(TM)?

The FDA product code for PNEUMO-SEAL(TM) is GCJ.

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Other records listing Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)K902232WECK ELECTROSURGICAL GENERATOR #174200

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Related Devices (Code: GCJ)

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.

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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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