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FDA 510(k)

FINE-JECT

K-Number: K983067 · 1998-10-30

ApplicantHenke Sass Wolf of America, Inc.
Decision Date1998-10-30
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FINE-JECT is the device name listed in this FDA 510(k) record. The listed applicant is Henke Sass Wolf of America, Inc.. It received FDA 510(k) clearance on 1998-10-30 under 510(k) number K983067. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINE-JECT?

FINE-JECT is a medical device that received FDA 510(k) clearance on 1998-10-30. The listed applicant is Henke Sass Wolf of America, Inc.. The 510(k) number is K983067.

When did FINE-JECT receive FDA 510(k) clearance?

FINE-JECT received FDA 510(k) clearance on 1998-10-30, under 510(k) number K983067.

Who is the listed applicant for FINE-JECT?

The FDA 510(k) record lists Henke Sass Wolf of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FINE-JECT?

The FDA product code for FINE-JECT is FMI.

Other records listing Henke Sass Wolf of America, 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.

K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEK050163HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPEK030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPEK013611HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPEK991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, CK981751SINUSCOPE AND ACCESSORIES

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Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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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