Cleared Traditional

K011997 - MODULAR VALVE HANDLES FOR ADAPTABLE TUBES

K011997 is an FDA 510(k) clearance for MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, manufactured by Pajunk GmbH. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K011997 · Pajunk GmbH · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2001
Decision
13d
Days
Class 2
Risk

K011997 is an FDA 510(k) clearance for the MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Pajunk GmbH (Geisingen, DE). The FDA issued a Cleared decision on July 10, 2001 after a review of 13 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 Pajunk GmbH devices

FDA 510(k) Submission Details - K011997

510(k) Number K011997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2001
Decision Date July 10, 2001
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Product Service, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 830
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K011997.
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
K011538 · Ethicon Endo-Surgery, Inc. · Aug 2001
ENDOPOUCH RETRIEVER
K011501 · Ethicon Endo-Surgery, Inc. · Jul 2001
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
K011257 · Ethicon Endo-Surgery, Inc. · Jul 2001
MODIFICATION TO KSEA ENDOTIP SYSTEM
K011359 · KARL STORZ Endoscopy-America, Inc. · Jun 2001
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
K010870 · Ethicon Endo-Surgery, Inc. · Jun 2001
LAPAROSCOPIC HAND PORT
K003871 · Applied Medical Resources Corp. · May 2001

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.