Who is the manufacturer of ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES?

Debusk Knitting Mills, Div. Deroyal Industries filed the 510(k) submission for ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (K961097).

What is the FDA product code for ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES?

3M (not specified); Birtcher (not specified); ValleyLab (not specified).

Who can help prepare an FDA 510(k) submission like ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES

K961097 · Debusk Knitting Mills, Div. Deroyal Industries · GEI · Jun 3, 1996 · General, Plastic Surgery

Device Facts

Record ID	K961097
Device Name	ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
Applicant	Debusk Knitting Mills, Div. Deroyal Industries
Product Code	GEI · General, Plastic Surgery
Decision Date	Jun 3, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

Intended Use

The DeRoyal Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.

Device Story

Device acts as passive electrical interface adapter; connects electrosurgical grounding pad to electrosurgical unit (ESU) jack. Input: proprietary grounding pad connector; Output: target machine connector. Operation: direct wiring conversion; no circuit alteration; no performance impact on original circuit. Used in clinical settings (OR/procedure rooms) by surgical staff. Facilitates electrical compatibility between mismatched hardware components; ensures grounding circuit continuity for patient safety during electrosurgery.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through design comparison and functional similarity to legally marketed devices.

Technological Characteristics

Passive electrical adapter; direct wiring configuration; non-sterile; proprietary input connector; target machine output connector. No active components or software.

Indications for Use

Indicated for patients requiring electrosurgical procedures where grounding pad connector compatibility between the electrosurgical unit (ESU) and the grounding pad is needed.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

3M (not specified)
Birtcher (not specified)
ValleyLab (not specified)

Related Devices

K961087 — DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS · Debusk Knitting Mills, Div. Deroyal Industries · May 16, 1996
K984276 — DISPOSABLE ELECTROSURGERY GROUNDING PAD · E & M Engineering, Inc. · Feb 10, 1999
K960569 — DISPOSABLE PATIENT RETURN ELECTRODE · Erbe USA, Inc. · Mar 11, 1996
K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) · Paladin Medical, Inc. · Nov 3, 1999
K111262 — ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP · Olsen Medical · May 23, 2012

Submission Summary (Full Text)

{0} K 961097 JUN - 3 1996 DeRoyal Industries, Inc. Electrosurgical Grounding Pad Adapters 510(k) Summary ## SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED ## SUBMITTER INFORMATION NAME: DeRoyal Industries, Inc. ADDRESS: 200 DeBusk Lane Powell, TN 37849 TELEPHONE: (423) 938-7828 CONTACT: Debra F. Manning DATE OF PREPARATION: March 18, 1996 ## DEVICE NAMES NAME: DeRoyal Surgical (SurgiMate) Electrosurgical Grounding Pad Adapters COMMON/USUAL NAME: Electrosurgical Grounding Pad Adapters CLASSIFICATION NAME (if known): Electrosurgical Cutting & Coagulation Device & Accessories ## PREDICATE OR LEGALLY MARKETED DEVICES 3M Birtcher ValleyLab ## DEVICE DESCRIPTION The DeRoyal Surgical Electrosurgical Grounding Pad Adapter functions in the same manner as predicate devices in that it is used to connect one type of electrosurgical grounding pad to a particular type of jack on the electrosurgical cautery machine being used. Device Design/Materials Used/Physical Properties: The DeRoyal Grounding Pad Adapter is made of materials commonly used for their purpose. The concept of use is that the adapter converts one type of connection to another type of connection without any alteration of the circuit or any impact on the performance of the original circuit. ## DEVICE INTENDED USE The DeRoyal Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad does not match the intended jack of the ESU machine but its use would make the electrical connection compatible. ## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Input Connector | Proprietary grounding pad connector | Same | | Output Connector | Target machine connector | Same | | Sterility | Non-sterile | Same | | Circuit | Direct wiring from input connector to output connector | Same |