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FDA 510(k)

SCANLAN TUNNELER, SHEATH & TIP

K-Number: K851825 · 1985-07-12

ApplicantScanlan Intl., Inc.
Decision Date1985-07-12
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCANLAN TUNNELER, SHEATH & TIP is the device name listed in this FDA 510(k) record. The listed applicant is Scanlan Intl., Inc.. It received FDA 510(k) clearance on 1985-07-12 under 510(k) number K851825. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANLAN TUNNELER, SHEATH & TIP?

SCANLAN TUNNELER, SHEATH & TIP is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Scanlan Intl., Inc.. The 510(k) number is K851825.

When did SCANLAN TUNNELER, SHEATH & TIP receive FDA 510(k) clearance?

SCANLAN TUNNELER, SHEATH & TIP received FDA 510(k) clearance on 1985-07-12, under 510(k) number K851825.

Who is the listed applicant for SCANLAN TUNNELER, SHEATH & TIP?

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

What is the FDA product code for SCANLAN TUNNELER, SHEATH & TIP?

The FDA product code for SCANLAN TUNNELER, SHEATH & TIP is DWS.

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Other records listing Scanlan Intl., Inc. as applicant

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K960372SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEMK945474SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDERK911184SCANLAN/TAHERI VALVULOTOMEK864919SCANLAN (TM) VEIN/GRAFT HOLDERK864920SCANLAN (TM) INSTRUMENT TRAYK841521SCANLAN ENDARSECTOR

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Related Devices (Code: DWS)

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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