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FDA 510(k)

SIGMA 1 WOBBLER BIOPSY KIT

K-Number: K882673 · 1988-07-28

ApplicantKontron Instruments, Inc.
Decision Date1988-07-28
Product CodeFCH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIGMA 1 WOBBLER BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K882673. The device is classified under product code FCH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA 1 WOBBLER BIOPSY KIT?

SIGMA 1 WOBBLER BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K882673.

When did SIGMA 1 WOBBLER BIOPSY KIT receive FDA 510(k) clearance?

SIGMA 1 WOBBLER BIOPSY KIT received FDA 510(k) clearance on 1988-07-28, under 510(k) number K882673.

Who is the listed applicant for SIGMA 1 WOBBLER BIOPSY KIT?

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

What is the FDA product code for SIGMA 1 WOBBLER BIOPSY KIT?

The FDA product code for SIGMA 1 WOBBLER BIOPSY KIT is FCH.

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Other records listing Kontron Instruments, 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.

K932268MODIFICATIONS TO INTRA-AORTIC BALLOONSK925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERSK923603INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATIONK905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT IIK9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM

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Related Devices (Code: FCH)

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.

K852105MANAN UBK ULTRASONIC GUIDED BIOPSY KITManan Manufacturing Co., 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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