Cleared Traditional

K802671 - EMPTY TRANSFER BAGS (FDA 510(k) Clearance)

K802671 · Delmed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
-
Days
-
Risk

K802671 is an FDA 510(k) clearance for the EMPTY TRANSFER BAGS.

Submitted by Delmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1980.

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.

View all Delmed, Inc. devices

Submission Details

510(k) Number K802671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received October 27, 1980
Decision Date October 27, 1980
Days to Decision -
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -