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FDA 510(k)

KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS

K-Number: K943154 · 1994-12-06

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1994-12-06
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1994-12-06 under 510(k) number K943154. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS?

KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS is a medical device that received FDA 510(k) clearance on 1994-12-06. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K943154.

When did KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS receive FDA 510(k) clearance?

KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS received FDA 510(k) clearance on 1994-12-06, under 510(k) number K943154.

Who is the listed applicant for KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS?

The FDA product code for KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS is HRX.

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Other records listing KARL STORZ Endoscopy-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.

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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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