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FDA 510(k)

BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE

K-Number: K964597 · 1997-09-08

ApplicantBiosurgical Corp.
Decision Date1997-09-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Biosurgical Corp.. It received FDA 510(k) clearance on 1997-09-08 under 510(k) number K964597. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE?

BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE is a medical device that received FDA 510(k) clearance on 1997-09-08. The listed applicant is Biosurgical Corp.. The 510(k) number is K964597.

When did BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE receive FDA 510(k) clearance?

BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE received FDA 510(k) clearance on 1997-09-08, under 510(k) number K964597.

Who is the listed applicant for BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE?

The FDA 510(k) record lists Biosurgical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE?

The FDA product code for BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE is FMF.

Related Clinical Trials

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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Other records listing Biosurgical Corp. 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.

K000438MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSERK000048SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1K992351SEALOUETTE FIBRIN SEALANT APPLICATOR

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

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

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