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FDA 510(k)

VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X

K-Number: K003893 · 2001-03-01

ApplicantOratec Interventions, Inc.
Decision Date2001-03-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X is the device name listed in this FDA 510(k) record. The listed applicant is Oratec Interventions, Inc.. It received FDA 510(k) clearance on 2001-03-01 under 510(k) number K003893. 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 VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X?

VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K003893.

When did VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X receive FDA 510(k) clearance?

VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X received FDA 510(k) clearance on 2001-03-01, under 510(k) number K003893.

Who is the listed applicant for VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X?

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

What is the FDA product code for VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X?

The FDA product code for VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X is HRX.

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Other records listing Oratec Interventions, 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.

K013622NUCLEOTOMY INTRADISCAL CATHETERK003198VULCAN TAC PROBES, MODEL 911XXXK000691VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELSK992805ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)K994333ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIESK993967ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002

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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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