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FDA 510(k)

MEGA PARACENTESIS KIT

K-Number: K913382 · 1991-10-08

ApplicantMega Medical, Inc.
Decision Date1991-10-08
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEGA PARACENTESIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mega Medical, Inc.. It received FDA 510(k) clearance on 1991-10-08 under 510(k) number K913382. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGA PARACENTESIS KIT?

MEGA PARACENTESIS KIT is a medical device that received FDA 510(k) clearance on 1991-10-08. The listed applicant is Mega Medical, Inc.. The 510(k) number is K913382.

When did MEGA PARACENTESIS KIT receive FDA 510(k) clearance?

MEGA PARACENTESIS KIT received FDA 510(k) clearance on 1991-10-08, under 510(k) number K913382.

Who is the listed applicant for MEGA PARACENTESIS KIT?

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

What is the FDA product code for MEGA PARACENTESIS KIT?

The FDA product code for MEGA PARACENTESIS KIT is KKX.

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Other records listing Mega Medical, 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.

K915863MEGA AMNIOCENTESIS KITK913317MEGA ARTHROGRAM KITK913397MEGA ANGIOGRAM KITK912445MEGA CONTINUOUS EPIDURAL ANESTHESIA KITK912322MEGA SPINAL ANESTHESIA KITK912564MEGA PERICARDIOCENTESIS KIT

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Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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