Cleared Traditional

K820275 - ARTHROSCOPIC HARPOON

K820275 is an FDA 510(k) clearance for ARTHROSCOPIC HARPOON, manufactured by The Anspach Effort, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K820275 · The Anspach Effort, Inc. · Orthopedic device
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Feb 1982
Decision
10d
Days
Class 2
Risk

K820275 is an FDA 510(k) clearance for the ARTHROSCOPIC HARPOON. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1982 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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.

View all The Anspach Effort, Inc. devices

FDA 510(k) Submission Details - K820275

510(k) Number K820275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1982
Decision Date February 12, 1982
Days to Decision 10 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 122d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 415
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K820275.
ARTHROSCOPES & ASSOCIATED INSTRUMENTS
K821359 · Downs Surgical , Ltd. · May 1982
MINI-MICRO ARTHROSCOPIC SCAPEL
K820777 · The Anspach Effort, Inc. · May 1982
CANNUOATED TROCHAR
K820776 · The Anspach Effort, Inc. · Apr 1982
ARTHROSCOPIC LEG HOLDER
K811861 · Stryker Corp. · Jul 1981
ZIMMER ARTHROSCOPY SYSTEM
K811596 · Zimmer, Inc. · Jun 1981
SURGICAL INSTRUMENTS FOR USE W/ZIMMER
K811675 · Zimmer, Inc. · Jun 1981