Skytron Elite Surgical Tables

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K811311 ↗

FDA Product Code

GBC

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Stellar

  Class II

  FDA 510(k) K002463 Active Cleared 8 Nov 2000

• Skytron Elite 300 Surgery Table

  Class I

  FDA 510(k) K853479 Active Cleared 5 Sep 1985

• Skytron Universe Series Surgical Lights

  Class II

  FDA 510(k) K900211 Active Cleared 19 Mar 1990

• Skytron Model 610-2

  Class II

  FDA 510(k) K870045 Active Cleared 4 Feb 1987

• Skytron Model 130 Surgical Table

  Class I

  FDA 510(k) K873478 Active Cleared 24 Sep 1987

• Skytron Life Island 21

  Class II

  FDA 510(k) K926045 Active Cleared 27 Jul 1993

See all devices from Skytron, Div. the Kmw Group, Inc. →

• Are the Skytron Elite Surgical Tables designed for single-use or can they be reused in the operating room?

  The Skytron Elite Surgical Tables are reusable medical devices, as there are no indications of single-use or sterilization requirements specified in the provided data. They are intended for repeated use in clinical settings, including general and plastic surgery procedures, without any mention of disposable components or sterilization protocols.

• What types of surgical procedures are these tables primarily intended to support?

  The Skytron Elite Surgical Tables (Model 6302) are classified under FDA product code GBC and designed for use in general and plastic surgery procedures. Their adjustable positioning and support features ensure stability and precision during surgical interventions, making them versatile for these specialties.

• How are these tables regulated by the FDA, and what does the clearance process entail?

  These tables were cleared through the traditional 510(k) pathway (K811311), meaning they were determined to be substantially equivalent to a legally marketed predicate device. The clearance was granted under the FDA’s regulatory framework for Surgical Tables (product code GBC), with no mention of additional approvals like MRI compatibility or special sterilization requirements.

• Are there different models or sizes available for the Skytron Elite Surgical Tables?

  The provided data only specifies the Model 6302 as part of the Skytron Elite Surgical Tables line, with no additional details on variations in sizes or models. For specific configurations, you would need to consult the manufacturer’s latest product catalog or technical specifications.