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FDA 510(k)

R-PORT II LAPAROSCOPIC ACCESS DEVICE

K-Number: K073170 · 2007-12-03

ApplicantAdvanced Surgical Concepts
Decision Date2007-12-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

R-PORT II LAPAROSCOPIC ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Concepts. It received FDA 510(k) clearance on 2007-12-03 under 510(k) number K073170. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R-PORT II LAPAROSCOPIC ACCESS DEVICE?

R-PORT II LAPAROSCOPIC ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2007-12-03. The listed applicant is Advanced Surgical Concepts. The 510(k) number is K073170.

When did R-PORT II LAPAROSCOPIC ACCESS DEVICE receive FDA 510(k) clearance?

R-PORT II LAPAROSCOPIC ACCESS DEVICE received FDA 510(k) clearance on 2007-12-03, under 510(k) number K073170.

Who is the listed applicant for R-PORT II LAPAROSCOPIC ACCESS DEVICE?

The FDA 510(k) record lists Advanced Surgical Concepts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R-PORT II LAPAROSCOPIC ACCESS DEVICE?

The FDA product code for R-PORT II LAPAROSCOPIC ACCESS DEVICE is GCJ.

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Other records listing Advanced Surgical Concepts 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.

K232701Guardenia (GAR-1)K192898PneumoLinerK121309ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEK111407TRIPORT, TRIPORT+, TRIPORT15, QUADPORTK110004ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEK101794ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA

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Related Devices (Code: GCJ)

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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