Cleared Traditional

K980849 - SURGIN KIT

K980849 is an FDA 510(k) clearance for SURGIN KIT, manufactured by Surgin Surgical Instrumentation, Inc.. The device is a Class 2 Ophthalmic device with product code MSR cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K980849 · Surgin Surgical Instrumentation, Inc. · Ophthalmic device
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Jul 1998
Decision
154d
Days
Class 2
Risk

K980849 is an FDA 510(k) clearance for the SURGIN KIT. Classified as Tubing, Replacement, Phacofragmentation Unit (product code MSR), Class II - Special Controls.

Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on July 9, 1998 after a review of 154 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - the FDA ophthalmic 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgin Surgical Instrumentation, Inc. devices

FDA 510(k) Submission Details - K980849

510(k) Number K980849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1998
Decision Date July 09, 1998
Days to Decision 154 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 110d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSR Device Classification - Class 2, Special Controls

Product Code MSR Tubing, Replacement, Phacofragmentation Unit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 Ophthalmic devices follow this clearance model.