Cleared Traditional

SPONGE SYSTEM, ROSERING CONTAIN-COUNT (K782120) - FDA 510(k) Clearance

K782120 · Medline Industries, Inc. · General & Plastic Surgery device
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Dec 1978
Decision
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K782120 is an FDA 510(k) clearance for the SPONGE SYSTEM, ROSERING CONTAIN-COUNT.

Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1978.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K782120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received December 27, 1978
Decision Date December 27, 1978
Days to Decision -
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
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -