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FDA 510(k)

SWISSTEK 2000(TM) CAST REMOVAL SYSTEM

K-Number: K932653 · 1994-01-28

ApplicantCarapace, Inc.
Decision Date1994-01-28
Product CodeLGH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SWISSTEK 2000(TM) CAST REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carapace, Inc.. It received FDA 510(k) clearance on 1994-01-28 under 510(k) number K932653. The device is classified under product code LGH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWISSTEK 2000(TM) CAST REMOVAL SYSTEM?

SWISSTEK 2000(TM) CAST REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Carapace, Inc.. The 510(k) number is K932653.

When did SWISSTEK 2000(TM) CAST REMOVAL SYSTEM receive FDA 510(k) clearance?

SWISSTEK 2000(TM) CAST REMOVAL SYSTEM received FDA 510(k) clearance on 1994-01-28, under 510(k) number K932653.

Who is the listed applicant for SWISSTEK 2000(TM) CAST REMOVAL SYSTEM?

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

What is the FDA product code for SWISSTEK 2000(TM) CAST REMOVAL SYSTEM?

The FDA product code for SWISSTEK 2000(TM) CAST REMOVAL SYSTEM is LGH.

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 Carapace, 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.

K931722CARAPACE LABOR AND DELIVERY SETSK931822CARAPACE PELVIC EXAM TRAYSK931729I.V. START KITK931669CARAPACE DEBRIDEMENT KITSK931820CARAPACE STILLWATER BOWL SETK931760CARAPACE PACKING GAUZE TRAYS

View all 22 devices →

Related Devices (Code: LGH)

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.

K901677CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTERBuckman Co., Inc.K893380QCR SYSTEM I AND QCR SYSTEM IIBremer Mfg. & Tool Co., Inc.K895861DELTA-TECH(TM) CAST REMOVAL SYSTEMJohnson & Johnson Professionals, Inc.K873723PLASTER VACUUM, 230V MODEL NO. 4183-161Martin MedicalK873721PLASTER VACUUM, 115V MODEL NO. 4183-160Martin MedicalK873720CAST CUTTER, 230V MODEL NO. 4183-107Martin Medical

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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