Cleared Traditional

K970054 - TANDEMRX

K970054 is an FDA 510(k) clearance for TANDEMRX, manufactured by Boston Scientific Corp. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K970054 · Boston Scientific Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
34d
Days
Class 2
Risk

K970054 is an FDA 510(k) clearance for the TANDEMRX. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K970054

510(k) Number K970054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1997
Decision Date February 10, 1997
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1065
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