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FDA 510(k)

SLOTTED SOFT-TISSUE INSTRUMENT

K-Number: K841623 · 1984-07-11

ApplicantPlastafil, Inc.
Decision Date1984-07-11
Product CodeHWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SLOTTED SOFT-TISSUE INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Plastafil, Inc.. It received FDA 510(k) clearance on 1984-07-11 under 510(k) number K841623. The device is classified under product code HWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLOTTED SOFT-TISSUE INSTRUMENT?

SLOTTED SOFT-TISSUE INSTRUMENT is a medical device that received FDA 510(k) clearance on 1984-07-11. The listed applicant is Plastafil, Inc.. The 510(k) number is K841623.

When did SLOTTED SOFT-TISSUE INSTRUMENT receive FDA 510(k) clearance?

SLOTTED SOFT-TISSUE INSTRUMENT received FDA 510(k) clearance on 1984-07-11, under 510(k) number K841623.

Who is the listed applicant for SLOTTED SOFT-TISSUE INSTRUMENT?

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

What is the FDA product code for SLOTTED SOFT-TISSUE INSTRUMENT?

The FDA product code for SLOTTED SOFT-TISSUE INSTRUMENT is HWQ.

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 Plastafil, 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.

K841621BACK RADIUS CUTTERK841620FRONT RADIUS CUTTERK841625HOOKK841617STROVER HOOKK841626PUNCHK841629DRILL BIT

View all 13 devices →

Related Devices (Code: HWQ)

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.

K970360MITEK SUTURE RETROGRADERMitek ProductsK920621ACUFEX PASSING PINS AND SURGICAL WIREAcufex Microsurgical, Inc.K923381SOFT TISSUE EXPANDERAcufex Microsurgical, Inc.K885311MENISCUS MENDER II LOOPInstrument Makar, Inc.K843592VICO MICRO SURGICAL INSTRUMENTSVisitec Co.K841622SOFT-TISSUE INSTRUMENTPlastafil, Inc.

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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