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FDA 510(k)

CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000

K-Number: K980588 · 1998-08-18

ApplicantClarus Medical Systems, Inc.
Decision Date1998-08-18
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K980588. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000?

CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Clarus Medical Systems, Inc.. The 510(k) number is K980588.

When did CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 receive FDA 510(k) clearance?

CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 received FDA 510(k) clearance on 1998-08-18, under 510(k) number K980588.

Who is the listed applicant for CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000?

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

What is the FDA product code for CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000?

The FDA product code for CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 is GAD.

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Other records listing Clarus Medical Systems, 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.

K974579PERCSCOPE MODEL 2600K971584CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)K971455CLARUS MODEL 5197 SIGHTLITEK960915CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXXK962255CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)K955598CLARUS SPINEPEN MODEL 2126

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Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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