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FDA 510(k)

PLEURAL DRAINAGE RESERVOIR

K-Number: K820765 · 1982-04-15

ApplicantInnovative Surgical Products, Inc.
Decision Date1982-04-15
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEURAL DRAINAGE RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Products, Inc.. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820765. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEURAL DRAINAGE RESERVOIR?

PLEURAL DRAINAGE RESERVOIR is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Innovative Surgical Products, Inc.. The 510(k) number is K820765.

When did PLEURAL DRAINAGE RESERVOIR receive FDA 510(k) clearance?

PLEURAL DRAINAGE RESERVOIR received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820765.

Who is the listed applicant for PLEURAL DRAINAGE RESERVOIR?

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

What is the FDA product code for PLEURAL DRAINAGE RESERVOIR?

The FDA product code for PLEURAL DRAINAGE RESERVOIR is GCX.

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Other records listing Innovative Surgical Products, 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.

K843041HESLIN DISPOS. TUBING SETK840693DISPOSABLE SCLERAL GLOBE PLUGK840695PHACOEMULSIFICATION KITSK840694LENS INSERTION GLIDEK841072IRRIGATION, ASPIRATION TUBING SETSK832235DISPOSABLE VITRECTOMY HANDPIECE

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Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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