Cleared Traditional

K870900 - THE GRIPPER SEAL(TM)

K870900 is an FDA 510(k) clearance for THE GRIPPER SEAL(TM), manufactured by Pharmacia Deltec, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K870900 · Pharmacia Deltec, Inc. · General & Plastic Surgery device
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Mar 1987
Decision
26d
Days
Class 1
Risk

K870900 is an FDA 510(k) clearance for the THE GRIPPER SEAL(TM). Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 31, 1987 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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.

FDA 510(k) Submission Details - K870900

510(k) Number K870900 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 05, 1987
Decision Date March 31, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGX Tape And Bandage, Adhesive

All 186
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K870900.
LIGHTPLAST(TM)
K872975 · Beiersdorf, Inc. · Aug 1987
ANDOVER ADHESIVE TAPE, SURGICAL
K872593 · Andover Coated Products, Inc. · Aug 1987
ANDOVER MOLESKIN
K872594 · Andover Coated Products, Inc. · Aug 1987
MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE
K870021 · Avery Intl. · Feb 1987
MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM
K870092 · Avery Intl. · Feb 1987
MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM
K870093 · Avery Intl. · Feb 1987
K870900 · THE GRIPPER SEAL(TM)
Download PDF Pharmacia Deltec, Inc.