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FDA 510(k)

TBI NEEDLE

K-Number: K860582 · 1986-03-04

ApplicantHobbs Medical, Inc.
Decision Date1986-03-04
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TBI NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Hobbs Medical, Inc.. It received FDA 510(k) clearance on 1986-03-04 under 510(k) number K860582. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBI NEEDLE?

TBI NEEDLE is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Hobbs Medical, Inc.. The 510(k) number is K860582.

When did TBI NEEDLE receive FDA 510(k) clearance?

TBI NEEDLE received FDA 510(k) clearance on 1986-03-04, under 510(k) number K860582.

Who is the listed applicant for TBI NEEDLE?

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

What is the FDA product code for TBI NEEDLE?

The FDA product code for TBI NEEDLE is GAA.

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Other records listing Hobbs Medical, Inc. as applicant

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K241874Aspiration Catheter (2189)K182927Pulmonary Cytology BrushK093079TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-UK030765HOBBS MISTIFIER SPRAY CATHETERK933354HOBBS MEDICAL CLEANING BRUSHK922396FUJINON FORCEPS -- MODIFICATION

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Related Devices (Code: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, 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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