Cleared Traditional

K953669 - PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING

K953669 · Marketing Perspectives · General & Plastic Surgery device

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Sep 1995

Decision

46d

Days

Risk

K953669 is an FDA 510(k) clearance for the PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Marketing Perspectives (Dallas, US). The FDA issued a Cleared decision on September 22, 1995 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 - K953669

510(k) Number	K953669 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	August 07, 1995
Decision Date	September 22, 1995
Days to Decision	46 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

69d faster than avg

Panel avg: 115d · This submission: 46d

Pathway characteristics

Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code	MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class	-

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 144

Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K953669.

DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)

K954741 · Derma Sciences, Inc. · Nov 1995

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL

K954384 · Renaissance Pharmaceutical, Inc. · Oct 1995

DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING

K952775 · Deroyal Industries, Inc. · Oct 1995

DCURASOL GEL WOUND DRESSING

K953816 · Dpt Laboratories, Ltd. · Aug 1995

CURASOL GEL WOUND DRESSING

K953450 · Dpt Laboratories, Ltd. · Aug 1995

BURNSHIELD TRAUMA DRESSING

K952247 · Golightly International Corp. · Jul 1995

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.

Manufacturer of K953669

Marketing Perspectives

Dallas, TX · US

PAT LAMB

Regulatory profile

2 submissions 1 cleared

50% clearance rate · Active in General & Plastic Surgery

View all devices by Marketing Perspectives →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: September 22, 1995. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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